Pioglitazone as Second-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Treatment With Gemcitabine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Simmons Cancer Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00867126
First received: March 20, 2009
Last updated: April 2, 2009
Last verified: March 2009
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Purpose
RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment for pancreatic cancer.
PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in treating patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: pioglitazone hydrochloride Other: laboratory biomarker analysis Other: questionnaire administration Procedure: quality-of-life assessment |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Pioglitazone
Pioglitazone hydrochloride
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy [ Designated as safety issue: No ]
- Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy [ Designated as safety issue: No ]
- Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years [ Designated as safety issue: No ]
- Changes in ECOG performance status as measured at baseline, weekly during the first course of therapy, every 4 weeks during the rest of therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years [ Designated as safety issue: No ]
- Changes in symptoms and quality of life as measured by the validated FACT-Hep scale version 4 questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response (confirmed complete or partial response) as measured by RECIST criteria [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To describe changes in markers of insulin resistance, including serum adiponectin levels, standard glucose tolerance testing, and fasting serum glucose and insulin levels, in patients with previously treated metastatic adenocarcinoma of the pancreas treated with pioglitazone hydrochloride as second-line therapy.
- To describe changes in weight in these patients.
- To describe changes in ECOG performance status in these patients.
- To describe changes in symptoms and quality of life of these patients using the validated FACT-Hep scale version 4 questionnaire.
Secondary
- To determine the tumor response as measured by RECIST criteria in these patients.
- To determine the time to disease progression in these patients.
OUTLINE: Patients receive oral pioglitazone hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete a quality-of-life questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy.
Patients undergo blood sample collection at baseline, every 4 weeks during therapy, and then at the completion of therapy for laboratory biomarker studies. Samples are analyzed for levels of insulin resistance markers (adiponectin, glucose, and insulin).
After completion of study therapy, patients are followed monthly for 6 months and then every 3 months for 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Previously treated disease
- Disease progression after first-line gemcitabine hydrochloride-based chemotherapy
- Radiologically measurable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No NYHA class III-IV congestive heart failure
- No unstable angina
- No second malignancy except for localized nonmelanoma skin cancer
- No psychiatric or addictive disorders that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
- Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed
- More than 12 months since prior and no other concurrent thiazolinediones
- More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents
- No other concurrent anticancer therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867126
Locations
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
Sponsors and Collaborators
Simmons Cancer Center
Investigators
| Principal Investigator: | Yull E. Arriaga, MD | Simmons Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Regulatory Affairs Associate, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas |
| ClinicalTrials.gov Identifier: | NCT00867126 History of Changes |
| Other Study ID Numbers: | CDR0000637622, SCCC-02208 |
| Study First Received: | March 20, 2009 |
| Last Updated: | April 2, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Pioglitazone |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 22, 2013